On August 13, 2024 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, reported a business update and announced financial results for the second quarter of 2024 (Press release, PDS Biotechnology, AUG 13, 2024, View Source [SID1234645819]).
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"We are exiting the second quarter with momentum. We have aligned with the FDA on the design of the Phase 3 registrational trial of Versamune HPV + pembrolizumab compared to pembrolizumab as a potential treatment for first-line recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma ("HNSCC")," said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "This clinical trial is supported by the maturing data from our VERSATILE-002 Phase 2 trial, including encouraging survival, disease control response rates and safety data. We look forward to the presentation of updated data from the VERSATILE-002 trial at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2024 Congress in September."
Kirk Shepard, M.D., Chief Medical Officer stated, "As a result of the recent VERSATILE-002 trial results, we have revised the statistical endpoints of the VERSATILE-003 Phase 3 trial to provide additional robustness to our trial design. Our goal now is to work with our clinical research organization to initiate the trial of the combination, which we believe has potential as the first targeted immunotherapy for HPV16-positive HNSCC. We anticipate that future studies of PDS01ADC have the potential to provide additional clinical benefit to an effective targeted immunotherapy."
Recent Developments
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Announced alignment with FDA to initiate Phase 3 VERSATILE-003 trial in HPV16-positive first-line recurrent or metastatic HNSCC.
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This trial will be designed to investigate the combination of Versamune HPV + pembrolizumab compared to pembrolizumab, and this design reflects updated statistical endpoints based on recent and more mature survival data from the VERSATILE-002 trial.
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PDS Biotech has initiated preparatory activities in connection with the planned start of the Phase 3 VERSATILE-003 trial in Q4 2024.
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Abstract by Jared Weiss, M.D., UNC Lineberger Cancer Center (Lead Investigator), presenting updated data from the VERSATILE-002 trial evaluating first-line treatment with Versamune HPV in combination with KEYTRUDA (pembrolizumab) in patients with HPV16-positive recurrent/metastatic HNSCC accepted for presentation at the ESMO (Free ESMO Whitepaper) Congress 2024.
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Provided a survival data update from the ongoing VERSATILE-002 trial in HPV16-positive HNSCC based on data cut from May 17, 2024.
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Median overall survival is 30 months, consistent with data cut as of November 30, 2023.
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Abstract by Adam Grippin, M.D., Ph.D., of the University of Texas MD Anderson Cancer Center presenting updated results from the IMMUNOCERV trial evaluating treatment of high-risk locally advanced cervical cancer with Versamune HPV in combination with chemoradiotherapy accepted for oral presentation at the American Society for Radiation Oncology (ASTRO) Annual Meeting 2024.
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Abstract by Renee Donahue, Ph.D., of the National Cancer Institute presenting preliminary biomarker results from a Phase 2 trial evaluating treatment of biochemically recurrent prostate cancer with PDS01ADC in combination with enzalutamide accepted for oral presentation at the 12th Annual Meeting of the International Cytokine and Interferon Society 2024.
Second Quarter 2024 Financial Results
Reported net loss was approximately $8.3 million, or $0.23 per basic share and diluted share, for the three months ended June 30, 2024, compared to a net loss of $11.5 million, or $0.37 per basic share and diluted share, for the three months ended June 30, 2023. The decrease was due to lower operating expenses.
Research and development expenses decreased to approximately $4.5 million for the three months ended June 30, 2024, from $8.0 million for the three months ended June 30, 2023. The decrease of $3.5 million was primarily attributable to lower clinical trial and manufacturing costs.
General and administrative expenses decreased to approximately $4.2 million for the three months ended June 30, 2024, from approximately $4.7 million for the three months ended June 30, 2023. The decrease of $0.5 million was primarily attributable to lower personnel costs and professional fees.
Total operating expenses decreased to approximately $8.7 million for the three months ended June 30, 2024, from $12.7 million for the three months ended June 30, 2023.
Net interest expenses increased to approximately $0.5 million for the three months ended June 30, 2024, from $0.2 million for the three months ended June 30, 2023.
Cash and cash equivalents as of June 30, 2024, totaled approximately $57.7 million.